New York Embroidery Studio Trinity Non-Surgical Isolation Gown
The isolation gowns may not meet liquid-barrier performance requirements.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
New York Embroidery Studio, Inc., of Brooklyn, New York, recalled its New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large, Model Number NYES100-2, because the gowns do not consistently meet the minimum liquid-barrier performance required. The recall began on July 31, 2026, and was added to the FDA's Enforcement Report on September 23, 2026.
The gowns are packaged in inner packs of 10 and 100 gowns per shipping case. The recall covers 5,400 gowns distributed in Connecticut.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, Aami PB70 Level 2, X-Large.
- Model
- NYES100-2
- UDI-DI
- 10860008955149
- Lot
- B0676
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Connecticut.
- Event ID
- 99760
- Recall No.
- Z-3259-2026
- Company
- New York Embroidery Studio, Inc.Brooklyn, New York
- Hazard
- Device defect
- Quantity recalled
- 5,400 gowns
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
